Job Description
Job Title: Clinical Evaluations Specialist - Regulatory Documentation - Vision Science/ Ophthalmology background is preferred. REMOTE ROLE - candidates must be willing to work in EST/CST time zone, if required. Duration: 6 months contract (possible extension) Interviews: 2 Request id#4354-1 Job Description :
- The Clinical Evaluations Specialist is responsible for managing regulatory documentation related to clinical evaluations, particularly for Medical Device Regulation (MDR) remediation and Post Production Risk Reviews (PPRRs).
- This role requires strong expertise in clinical literature reviews, regulatory writing, and post-market surveillance activities to support the life cycle management of medical devices.
- The specialist will serve as a primary point of contact for clinical project leads and collaborate closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Clinical Development.
Key Responsibilities: Regulatory Documentation & Clinical Evaluation: - Author, revise, and update clinical documents for MDR remediation and PPRRs.
- Conduct systematic literature reviews and clinical data appraisals in alignment with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidance.
- Review and summarize large clinical documents such as literature reports, clinical research protocols, and templates.
- Assist in the development and maintenance of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Plans and Reports, and risk-benefit analyses.
- Support regulatory submissions by ensuring all clinical documentation meets scientific and regulatory standards.
Life Cycle Management & Risk Assessment: - Act as clinical contact for Life Cycle Management (LCM) and Post Production Life Cycle Management (PPLCM) activities.
- Provide clinical functional review and expertise on assigned projects, ensuring compliance with global regulatory requirements.
Process Improvement & Compliance: - Monitor evolving EU MDR, FDA, and ISO 14155 regulations to ensure compliance with clinical evaluation processes.
- Develop and improve standard operating procedures (SOPs) related to clinical regulatory documentation.
- Track and analyze quality metrics related to clinical evaluations and risk reviews.
Required Qualifications: - Master's or Ph.D. in Vision Science, Biomedical Engineering, Life Sciences, or related field.
- Foreign-trained ophthalmologists are encouraged to apply.
- Proficiency in European Medical Device Regulations (MDR), particularly in clinical evaluations and post-market surveillance.
- Experience in writing and reviewing clinical evaluation reports (CERs), literature reviews, and clinical risk assessments.
- Strong background in regulatory compliance, medical writing, and scientific research methodologies.
- Proficient in Microsoft Office Suite and regulatory documentation software.
- Strong communication and writing skills.
Preferred Qualifications: - Experience in eye care/ophthalmology is highly preferred.
- Experience in conducting systematic literature reviews and regulatory risk analysis.
- Knowledge of clinical trial registries, biostatistics, and regulatory intelligence.
- Certification in Regulatory Affairs (RAC), Medical Writing (AMWA, EMWA), or a related field.
Job Tags
Contract work, Remote job,